A Smartphone Intervention for WIC Mothers to Improve Nutrition and Weight Gain During Pregnancy (SmartMomsinWIC)

SmartMoms in WIC: A Smartphone Intervention for WIC Mothers to Improve Nutrition and Weight Gain During Pregnancy

The study will test the effectiveness of a smartphone-based behavior modification program adapted for use in Women, Infants, and Children program in a state-wide, randomized controlled trial in 432 low-income women enrolled in the Louisiana Women, Infants, and Children program.

Study Overview

• Status: Active, not recruiting
• Conditions: Weight Gain During Pregnancy
• Intervention / Treatment: Behavioral: Healthy Beginnings

Detailed Description

The study is a multi-site randomized controlled trial, testing the effectiveness of the smartphone-based behavior modification program in pregnant women within the Louisiana Women, Infants, and Children program. Equal number of participants will be randomized to either the intervention or the control. Although the intervention itself lasts 24 weeks (only during pregnancy), women will be enrolled in this study for approximately 18 months, from the 10-16th week of pregnancy until 12 month postpartum follow-up. Study outcomes will be assessed at three visits during pregnancy (early, mid, and late,) and three visits postpartum (1, 6, and 12 months).

• Study Type: Interventional
• Enrollment (Actual): 351
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abby D Altazan, M.S.; Phone Number: 225-763-2801; Email: Abby.Altazan@pbrc.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Less than 16 weeks gestational age at screening visit
• Have a BMI of 18.5 to 40 kg/m2
• Expecting a singleton pregnancy
• Certified to receive Women, Infants, and Children services during current pregnancy
• Has smartphone with internet access
• Willing to be identifiable to other study participants in this study program

Exclusion Criteria:

• Smoking
• Drug or alcohol use
• Non-pregnancy related illness
• Hypertension at screening visit
• Current mental health issue or eating disorder
• Inability to complete a behavioral run-in task
• Plans to move out of the state in the next 18 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: WIC Nutrition; Participants will receive weight management advice and care through the standard Women, Infants, and Children program. They will also receive weekly health information related to pregnancy, birth, and infant health through a closed Facebook group.
Experimental: Healthy Beginnings; Participants will receive the SmartMoms smartphone application, a wireless connected scale, and a Fitbit. The Healthy Beginnings program includes a 24 week intensive behavior modification program that targets healthy gestational weight gain through self-monitoring of weight and activity data, automated prescriptive feedback from the SmartMoms smartphone application, personalized feedback from counselors, and evidence-based behavioral intervention delivered throughout pregnancy.	Behavioral: Healthy Beginnings; The program includes a 24 week intensive behavior modification program that targets healthy gestational weight gain through self-monitoring of weight and activity data, automated prescriptive feedback from the smartphone application, personalized feedback from counselors and, evidence-based behavioral intervention delivered throughout pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Women Who Have Excess Gestational Weight Gain	Number of pregnant women who gain more weight during pregnancy than is recommended by the Institute of Medicine Gestational Weight Gain guidelines	Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Gestational Weight Gain		Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)
Gestational Weight Gain Per Week	"per week" is included to adjust for the different length of time between weight measurements	Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: Louisiana Department of Health
• Investigators: Principal Investigator: Leanne M Redman, Ph.D., Pennington Biomedical Research Center

Publications and helpful links

General Publications

• Flanagan EW, Altazan AD, Comardelle NR, Gilmore LA, Apolzan JW, St Romain J, Hardee JC, Puyau RS, Mayet CL, Beyl RA, Barlow SA, Bounds SS, Olson KN, Kennedy BM, Hsia DS, Redman LM. The Design of a Randomized Clinical Trial to Evaluate a Pragmatic and Scalable eHealth Intervention for the Management of Gestational Weight Gain in Low-Income Women: Protocol for the SmartMoms in WIC Trial. JMIR Res Protoc. 2020 Sep 10;9(9):e18211. doi: 10.2196/18211.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2019
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Body Weight; Weight Gain
• Other Study ID Numbers: PBRC IRB# 2018-039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data can be shared with appropriate material/data use agreements but there are no current plans.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No